The present invention relates to surgical instruments and more particularly to the provision of Minimally Invasive Surgery (MIS) surgical instruments which are easily separable or the parts of which are releasably separable for cleaning and sterilizing and repair or replacement.
Various types of MIS surgery are now being performed by surgeons including laparoscopy, endoscopy and arthroscopy surgery. Surgical instruments usable in MIS surgery very commonly have a proximal end to be disposed outside the patient's body, a distal end to be disposed inside the patient's body and a support shaft or a barrel portion extending between the proximal end and the distal end. A handle mechanism or handle portion is disposed at or adjacent the proximal end of the instrument to provide means for gripping and manipulating the instrument. Typically, the handle portion will include a base handle grippable by the surgeon to hold and manipulate the instrument and a movable handle or trigger also manipulable by the surgeon, usually by a digit of the same hand that holds the base handle.
Various types of operating units are placed on the distal end of the instrument including scissors, various types of cutters, graspers, staple applicators, clip applicators, laser devices, viewing (optical) devices, illuminating devices, and any combination of these. In this specification, and in the appended claims, the term "operating unit" which is said to be mounted on the distal end of the instrument is some sort of unit for affecting and/or viewing tissue within the patient's body. Such operating units conventionally have at least one movable member, and some have two or more movable members. Essentially, the at least one movable member is the action member which, when moved relative to the shaft portion or barrel of the instrument, will cooperate with a stationary member somehow to affect or view the tissue of the patient's body. For instance, the at least one movable member may be a scissors blade, a grasper jaw, a staple driver, etc. The movable member may also be a lens of a fiber optic viewing system.
Conventionally, MIS instruments of the type described include a drive actuator or a drive member which extends along the barrel portion or support shaft to move rectilinearly or rotatably to move the at least one movable member of the operating unit. This drive actuator typically will be driven rectilinearly along the support shaft or barrel portion by pivotal or swinging movement of the movable handle or trigger of the handle mechanism at the proximal end of the instrument. The actuator may also be rotated about its axis relative to the support shaft to move at least one movable member.
Such MIS surgery instruments are very well known. Currently, many of such instruments are made to be disposable or intended for single use. In order to be used in MIS surgery, these instruments must be rather small and the parts thereof must be rather confined within the small diameter of the support shaft or barrel portion. Many of these instruments are used in rather small incisions or rather small cannulae or trocars extending into joints or through the abdominal wall of a patient. The basic concept behind MIS applications is to make rather small incisions or openings, typically 3 to 5 to 11 mm, in the patient to accommodate the operating or viewing units at the distal end of the instruments.
It is very expensive to dispose of these MIS instruments after a single patient use. The units are expensive and the disposal processes are expensive. Further, there are environmental problems associated with taking such disposable instruments to landfills and other disposal sites and systems. Another problem with single use or disposable instruments is that some hospitals and staff members are known to reuse them after at least an effort to sterilize them.
Sterilizing and cleaning these very small instruments, even if such an activity is attempted, is rather problematical using instruments of the prior art designs. Currently there are no cleaning devices to forcibly flush the body fluids and tissues, sometimes referred to as "bioburden", out of such narrow and confined spaces within MIS instruments after surgery. It is a matter of serious concern to surgeons that such cleaning activities be effective to clean and to sterilize the instruments. If toxic chemicals and/or gases are used in an attempt to clean and sterilize the instruments, there is always the possibility that such chemicals or gases will be trapped in the instruments to escape during surgery exposing both the patient and the health care professionals.
Recent clinical research has shown that tuberculosis, HIV, and some forms of hepatitis, in particular, are capable of surviving common sterilization methods, possibly to allow cross-contamination between patients or transmission to health care workers. It is reported that in 1991, about 200 health care workers died from hepatitis and nearly 9,000 health care workers were exposed to it.
While there are reusable MIS instruments and health care establishments are attempting to clean and sterilize them after each use, the operating units at the distal ends and the barrel portions or support shaft portions are very difficult to clean simply by soaking in chemicals and/or by autoclaving. In order to save on cost per patient and minimize environmental problems, MIS instruments need to be developed which can be thoroughly and easily cleaned, sterilized, and which can be reliably inspected after each surgery application.
The present invention, therefore, contemplates providing MIS instruments in which at least the portions of the instrument which are inserted within the patient are readily separable or openable for cleaning, sterilizing, and inspection purposes without use of tools.
It is an object of the present invention, therefore, to provide such an easily cleanable MIS instrument comprising a handle mechanism including a base handle grippable by a surgeon to hold and manipulate the instrument, a movable handle or trigger for manipulation by the surgeon, and means for providing a movable connection between the base handle and the movable handle. Then, a barrel portion extending away from the base handle is provided, the barrel portion having a distal end portion to be inserted in the patient's body during MIS surgery. A drive actuator extends along the barrel portion to be movable by the movable handle, and means for providing a driving connection between the movable handle and the drive actuator is provided. The driving connection means is preferably disengageable from the drive actuator to permit the drive actuator to be moved away from the barrel portion to permit access for cleaning of the barrel portion and actuator after the MIS surgery.
It is another object of the present invention to provide such a MIS instrument in which the drive actuator is separable from or releasable from the support shaft or barrel portion to accommodate or facilitate the cleaning, sterilizing and inspection activity. In one embodiment of the present invention, the drive actuator is hingedly or pivotally connected to the distal portion of the instrument to be swung away from the handle portion and barrel portion upon release. The distal end of the drive actuator is preferably drivingly connected to the at least one movable member of the operating unit at the distal end of the instrument. When the drive actuator is moved away from the barrel potion, the operating unit and its parts are better exposed for cleaning, sterilizing and inspection.
Still another object of the present invention is to provide a MIS surgical instrument comprising a support shaft having a proximal end extending outside the patient's body during surgery and a distal end extending inside the patient's body during the surgery. The shaft is elongated and generally rigid such that movement of the proximal end relative to the patient will position the distal end within the patient. A handle is rigidly attached to the proximal end of the support shaft to provide means for gripping the instrument. An operating unit is mounted on the distal end of the support shaft for use on and/or viewing tissue within the patient's body. This operating unit has at least one movable action member such as a cutter, grasper or lens for affecting or viewing the patient's tissue within the body. A drive member or drive actuator extends longitudinally along the support shaft to provide a driving connection between the handle and the said at least one action member. This driving connection may be for rectilinear shifting movement or rotating movement. A trigger member is supported on the handle for movement, and means for providing an operative connection between the trigger member and the drive member is provided at the handle such that a surgeon may hold the handle and move the trigger member to move (rotate or shift) the drive member and the at least one action member. In this embodiment, means are provided for releasably connecting the drive member to the instrument such that the drive member can be moved away from the support shaft to accommodate sterilizing, cleaning and inspection of the shaft and the operating unit.
An increasingly recognized major factor in sterilizing instruments is minimizing the amount of both original and remaining bioburden which may contain the pathogens. The design of the present invention minimizes bioburden during surgery and eliminates it after cleaning and sterilizing processes. The design of the present invention is easily serviceable and cleanable without tools for the purpose of preventing serious bacterial and viral infections when the instruments are reused. These features are accomplished in the illustrative and preferred embodiment by having the elongated support shaft or barrel portion formed to have a trough-like slot having a generally U-shaped cross section or at least an open slot extending longitudinally along the support shaft. The drive actuator is illustratively and preferably mounted to move in and out of this slot, to be in the slot during the operation for providing a driving connection between the movable handle or trigger and at least one movable member of the operating unit and to be out of the slot during cleaning, sterilizing and inspection. In the illustrative embodiment, the drive actuator is pivotally or hingedly connected to the distal end of the support shaft or to the movable member of the operating unit and through that member to the support shaft to swing away from the handle portion and the support shaft. In this embodiment, the handle portion is correspondingly slotted to receive the drive actuator. Means are provided within the handle portion to lock the drive actuator in its operating position and means are provided drivingly to connect the movable handle to the drive actuator.
In this illustrative and preferred embodiment, the slotted support shaft and the slotted handle portion receive the drive actuator, and the drive actuator has a cross-sectional shape such that it does not close the support shaft or slot through the handle portion to leave a through passageway communicating from outside the patient to the operating unit at the distal end of the support shaft.
It is another object of the present invention, therefore, to provide such a MIS instrument in which the drive actuator is disposed in a slot in the support shaft and received in a trough or slot in the handle portion to define a passageway through the handle portion and the support shaft through which other instruments such as fiber bundles for laser action or illumination or viewing may be disposed and through which other surgical activities such as laser treatment, viewing or cauterizing may be accomplished. In this embodiment of the present invention, the support shaft, drive actuator and handle are configured to provide a longitudinally directed through passageway for lighting and/or visualization, laser, suction or injection of fluid or gas through the instrument. Fibers or tubes of various types may be placed in or inserted through this passageway. This embodiment contemplates that the traditional cutting or grasping instruments used in MIS surgery may also be used for lighting and/or visualization, laser, suction or injection of liquid or gas, as well as other types of treatment processes such as cauterizing.
It is still another object of the present invention to provide a finger-operable lock which secures the drive actuator in its operating position relative to the support shaft and instrument handle. This finger-operable lock releases the actuator to pivot or swing at the distal end of the support shaft fully out of the slot in the support shaft to accommodate cleaning.
Further to enhance the cleanability of the MIS instrument of the present invention, the support shaft itself is connected to the handle portion for easy separation simply by releasing a finger-actuated locking mechanism. In the illustrative and preferred embodiment, the proximal end of the support shaft is proportioned and designed to slide into a receiver section, preferably an open slotted portion of the handle, to be snugly received in the receiver section and firmly attached to the handle by the finger-actuated locking mechanism. Another feature of the illustrative and preferred embodiment is to have the operating unit, for instance the scissors or graspers, at the distal end of the support shaft also be removably attached to the distal end for cleaning and/or replacement.
It is still a further object of the present invention, therefore, to have a MIS instrument of the type discussed above in which the drive actuator is removable or releasable from the support shaft and handle also to have the support shaft be removable or releasable from the handle and to have the operating unit removable or releasable from the distal end of the support shaft.
In another embodiment of the present invention the support member of the surgical instrument is curved to facilitate accessibility by a surgeon. In this instance, the drive actuator is configured to include the plurality of notched or relieved sections at a location adjacent the curved portion of the support member. The curved support member has an operating unit formed integrally with a distal end. A proximal end of the curved support member is configured to be removably coupled to an open end of the handle assembly.
The body of the handle assembly is advantageously configured to allow easy removal of the tip assembly from the handle body by a surgeon in the field. The primary purpose for such removability is to permit field repairability by like kind tip assemblies. In other words, a surgeon can remove a tip assembly for repair or replacement with a like kind tip assembly without having to send the entire surgical instrument back to the manufacturer for repair. Thus by having a spare tip assembly on hand, the instrument can be returned to service before the next surgery.
The design of the body of the handle assembly also advantageously permits quick removal of the tip assembly from the handle body by a surgeon in the operating room. Therefore, a surgical kit may be provided for use by a surgeon during an operation. The kit includes a handle assembly and a plurality of different tip assemblies which each include the elongated support member having a proximal end configured to be removably coupled to the handle assembly and an operating unit formed at a distal end of the support member for performing a particular surgical procedure. The plurality of tip assemblies in the kit include straight support members and both right curved support members and left curved support members. In addition, various types of instruments may be included for the operating units on the straight and curved support units. For example, cutters, graspers, forceps, punches, scissors, or any other type of surgical instrument can be formed on the distal end of the straight and curved tip assemblies in the kit. Advantageously, a surgeon can quickly unlock and remove a particular tip assembly from the handle during a surgical procedure. For instance, the surgeon could remove a straight tip assembly and decide to insert a right curved or left curved tip assembly to facilitate a particular surgical procedure. The kit of the present invention makes it possible for the surgeon to quickly remove and select a most advantageous tip assembly for use in the surgical procedure. Therefore, the kit of the present invention advantageously provides the surgeon the ability to replace the entire tip assembly in seconds, even in the sterile field during surgery. In addition, because the tip assemblies are removable from the handle, the entire instrument does not have to be returned to the manufacturer for repair. This has many advantages, particularly eliminating the transportation of possibly hazardous bioburden, and not having the instrument out of service for up to the several weeks. This greatly reduces costs.
Another advantage of the present invention is that the various components of the tip assembly are coupled together to prevent the components of the tip assembly from being separated or disassembled. If the tip assembly were disassembled, it is likely that it would take an extended period of time to reassemble the small parts without a microscope or magnifier. Such disassembly would also increase the likelihood of damage to the components of the tip assembly. The drive actuator is locked into the operating unit by a round cylinder on one side of the distal end of the actuator which is inserted into the recess of the operating unit. A side plate or stop is welded on to the operating unit, preventing disassembly of the operating unit from the drive actuator. Finally, after assembly of the cutter/actuator sub-assembly into the tip, a pair of stops are welded to the tip to prevent the operating unit from rotating out of or derailing from the tip pivot arc on the support member. Therefore, the tip assembly cannot be disassembled either accidentally or on purpose without major force and destruction of the tip assembly.
According to one aspect of the present invention, a surgical instrument includes a handle having a movable trigger, and an elongated support member having a proximal end coupled to the handle and a distal end for insertion into a patient's body. The elongated support member includes a curved portion located in close proximity to the distal end. The elongated support member is formed to include a slot extending from the proximal end to the distal end. The surgical instrument also includes an operating unit coupled to the distal end of the support member, and a drive actuator configured to be positioned in the slot of the support member. The drive actuator has a distal end and a proximal end. The distal end of the drive actuator is coupled to the operating unit and the proximal end of the drive actuator is configured to engage the trigger so that the drive actuator moves the operating unit relative to the support member in response to movement of the trigger.
In the illustrated embodiment, the drive actuator has a predetermined thickness and includes a relieved section having a reduced thickness located adjacent the curved portion of the support member. This relieved section of the drive actuator permits the drive actuator to bend as it moves through the curved portion of the support member. The relieved section includes a plurality of spaced apart ribs having substantially the predetermined thickness to position the relieved section of the drive actuator in the slot of the support member.
Also in the illustrated embodiment, the surgical instrument includes a locking member for removably coupling the proximal end of the drive actuator to the handle. The locking member is movable from a first position to hold the drive actuator in a locked position relative to the handle to a second position to release the drive actuator from the handle and to permit movement of the drive actuator away from the handle. Such pivotal movement of the device actuator permits cleaning, sterilization, and inspection of the support member, the drive actuator, and the operating unit after a surgical procedure.
According to another aspect of the present invention, a surgical instrument includes a handle having a movable trigger, an elongated support member having a proximal end coupled to the handle and a distal end for insertion into a patient's body, an operating unit pivotably coupled to the distal end of the support member, and a drive actuator having a distal end and a proximal end. The proximal end of the drive actuator is configured to engage a portion of the movable trigger, and the distal end of the drive actuator is pivotably coupled to the operating unit for moving the operating unit relative to the support member in response to movement of the trigger. The surgical instrument also includes a first stop formed on the operating unit to prevent disengagement of the distal end of the drive actuator from the operating unit, and a second stop formed on the support member to prevent disengagement of the operating unit from the support member.
According to yet another aspect of the present invention, a surgical instrument includes a removable tip assembly having an elongated support member including a proximal end configured to be coupled to the handle and a distal end for insertion into a patient's body. The tip assembly also includes an operating unit coupled to the distal end of the support member, and a drive actuator having a distal end and a proximal end. The distal end of the drive actuator is pivotably coupled to the operating unit for moving the operating unit relative to the support member. The surgical instrument also includes a handle having a body portion formed to include an opening for slidably receiving the proximal end of the tip assembly therein, a movable trigger configured to actuate the operating unit of the selected tip assembly, and a locking mechanism for removably coupling the selected tip assembly to the handle. Using only a simple screwdriver type tool, the locking mechanism is movable from a first position to hold the selected tip assembly in a locked position relative to the handle to a second position to release the selected tip assembly from the handle and permit the removal of the selected tip assembly from the handle.
In the illustrated embodiment, the locking mechanism includes a semi-cylindrical member for engaging a notch formed in the support member to secure the support member to the handle. The locking mechanism also includes means coupled to the semi-cylindrical member for rotating the semi-cylindrical member to release the support member from the handle.
According to still another aspect of the present invention, a surgical instrument kit is provided. The kit includes a first removable tip assembly including a straight support member having a proximal end configured to be coupled to the handle and a distal end for insertion into a patient's body. The distal end of the support member of the first tip assembly is formed to include an operating unit thereon. The kit also includes a second removable tip assembly including a curved support member having a proximal end configured to be coupled to the handle and a distal end for insertion into the patient's body. The distal end of the curved support member is formed to include an operating unit thereon. The kit further includes a handle having a body portion configured to receive the proximal end of a selected one of the first and second tip assemblies therein, a movable trigger configured to actuate the operating unit of the selected tip assembly, and a locking mechanism for removably coupling the selected tip assembly to the handle. The locking mechanism is movable from a first position to hold the selected tip assembly in a locked position relative to the handle to a second position to release the selected tip assembly from the handle and permit the removal of the selected tip assembly from the handle.
Additional objects, features, and advantages of the invention will become apparent to those skilled in the art upon consideration of the following detailed description of the preferred embodiments exemplifying the best mode of carrying out the invention as presently perceived.